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Eli Lilly’s COVID-19 antibody scores FDA emergency use approval

Drug authorised to treat mild-to-moderate COVID-19

Eli Lilly’s monoclonal antibody treatment bamlanivimab has been granted an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the treatment of COVID-19.

The EUA covers bamlanivimab 700mg for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients. It is not authorised, however, for patients who are hospitalised as a result of COVID-19 or who require oxygen therapy due to COVID-19.

According to the FDA, monoclonal antibodies like bamlanivimab could be associated with ‘worse clinical outcomes’ when given to hospitalised COVID-19 patients who require high flow oxygen or mechanical ventilation.

Bamlanivimab’s EUA is based on an interim analysis from the phase 2 BLAZE-1 clinical trial of 465 non-hospitalised adults with mild-to-moderate COVID-19 symptoms

Within this patient population, 101 received a 700mg dose, 107 received a 2,800mg dose and 101 received a 7,000mg dose of bamlanivimab. In addition, 156 received a placebo within three day of obtaining the clinical sample for the first positive SARS-CoV-2 viral test.

The trial’s primary endpoint was a change in viral load from baseline to day 11 for bamlanivimab versus placebo – most patients, including those on placebo, cleared the virus by day 11.

However, for patients with a high risk of disease progression, hospitalisation and accident and emergency (A&E) visits occurred in 3% of bamlanivimab-treated patients compared to 10% of placebo-treated patients.

This result in particular is the ‘most important evidence that bamlanivimab may be effective’ for the treatment of COVID-19, according to the FDA.

The effects on viral load, reductions in hospitalisations and A&E visits and safety were similar across all three bamlanivimab doses tested.

"The BLAZE-1 data shows bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalisations, supporting our belief that neutralising antibodies can be an important therapeutic option for patients fighting this virus," said Daniel Skovronsky, chief scientific officer of Lilly and president of Lilly Research Laboratories.

Lilly said in a statement that it will begin shipping the antibody immediately to AmerisourceBergen, which is set to distribute the treatment as instructed by the US government’s allocation programme.

Another drugmaker, Regeneron, is also looking to obtain an EUA from the FDA for its COVID-19 antibody cocktail, REGN-COV2.

Similar to Lilly, Regeneron has submitted its antibody treatment under the EUA process for the treatment of mild-to-moderate high-risk outpatients with COVID-19.

In October, Regeneron published results for REGN-COV2 which showed that the antibody cocktail induced a greater than ten-fold reduction in viral load compared to placebo.

After 29 days of treatment, 2.8% of patients receiving REGN-COV2 at either the 8g or 2.4g doses had a medical visit because of their symptoms, compared to 6.5% receiving placebo.

Medical visits were reduced by 72% in patients with one or more risk factors who were receiving the investigational antibody cocktail, Regeneron said.

Article by
Lucy Parsons

10th November 2020

From: Regulatory



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